Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

Part of paid clinical trials in Wilmington, North Carolina.

Sponsor
Ipsen
Study ID
NCT06258902
Status
Recruiting
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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, and Albireo pharmacovigilance. Study start date is either start of data collection or first patient enrolled whatever occurs earlier. The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected. No additional laboratory tests or HCP assessments will be required as part of this surveillance program.

Key Dates

Start date
Sep 28, 2023
Status verified
May 2026
Primary completion
May 31, 2032
Completion
May 31, 2032

Study Design

Enrollment
20 participants (estimated)

Primary Outcome Measure

Prevalence rate of major congenital malformations (MCM) at birth [ Time Frame: At birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance ProgramWilmingtonNorth Carolina28401-

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Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program· Wilmington, NC

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